The UK Stem Cell Tool Kit

The UK Stem Cell Tool Kit is intended to be a reference tool for those who wish to develop a programme of human stem cell research and manufacture, including clinical applications. The Tool Kit applies only to the regulation of human stem cells and their use in the laboratory and clinical settings and replaces the Interim UK Regulatory Route Map for Stem Cell Research & Manufacture published in March 2009. The Tool Kit does not cover the use of animal stem cells in non-clinical settings. You do not need to register to use this Tool Kit. The content of this website will be reviewed formally every Quarter by the developers of the UK Stem Cell Tool Kit to ensure the information provided is as accurate and up-to-date as possible.

Viewing the Tool Kit

Regulatory routes may be viewed in three different ways in this Tool Kit:

(1) 'Map View' generates a graphical representation of the regulatory route for your stem cell project in response to a series of questions. Each step is colour-coded based on whether it is a regulatory question (light blue), a statutory regulatory process (red), non-statutory good practice (dark blue) or a research or manufacturing activity (black). After answering each question, the map automatically scrools down to the next question. You can view any point in your regulatory map by scrolling up and down the map whilst keeping your mouse button depressed. On a double button mouse, use the left one as you scroll. You can email, print or save your map in Map view.

(2) 'Question View' generates a series of regulatory questions in text format, the answers to which allow users to generate the regulatory route map for their project. For each new question, an 'Info' button allows users to explore in more detail the rationale behind the question. The regulatory, research or manufacturing steps, called 'Milestones', that will occur subsequent to a positive or negative response to each paticular question, are listed below each question. Users can click on each of these Milestones to obtain more information. The answers to previously-asked questions are displayed on the right hand side of the screen.

(3) 'Project View' allows you to see in its entirety the detailed information behind each of the steps in the regulatory route map for your project. Click on each individual box to reveal information relevant to each of the regulatory steps on the route for your project. Alternatively, click on the 'Expand All' button to open up all of the boxes for teach of the regulatory steps in the project. You can print your route map from Project View. We recommend that you start work from the 'Project View' version of your route map once you are familiar with the Tool Kit and the overall regulatory route for your project.

Key Regulatory Questions

In general, it will not be possible to determine with any degree of certainty the exact regulatory route for a given application without first consulting directly with the appropriate regulatory bodies. To establish the most appropriate regulatory route for a given stem cell therapy, there are a number of key questions to consider first. These are:

Q1. Is the final material intended for Human Application? Discuss with the HTA (enquiries@hta.gov.uk)

Q2. Will the stem cells be derived from Human Embryo? Discuss with the HFEA (admin@hfea.gov.uk)

Q3. Will the cells be Genetically Modified? Discuss with the HSE (Notificationofficer@hse.gsi.gov.uk)

Q4. Will the therapy be manufactured into a Medicinal Product or Investigational Medicinal Product? Discuss with the MHRA (info@mhra.gsi.gov.uk)

Q5. Is the Product to be Licensed? Discuss with the MHRA (info@mhra.gsi.gov.uk)

Q6. Is Animal in vivo work required? Discuss with the MHRA (info@mhra.gsi.gov.uk) & Home Office (020 7035 4785)

Q7. Will the clinical research involve a genetically modified product? Discuss with the HSE (Notificationofficer@hse.gsi.gov.uk) & GTAC (gtac@dh.gsi.gov.uk)

Route Codes

You do not need to register to use this Tool Kit. Instead of saving a new regulatory route map every time you use this Tool Kit, a unique code to identify that route is created which can be subsequently used to access that particular route when you return again to the site. The code consists of a Letter, signifying whether the route will be displayed as a ‘Map View' (M), ‘Project View' (P), or ‘Question View' (Q), followed by a hyphen and five digit number specifying that particular regulatory route. You can simply record manually, or email to yourself or others using the email buttons on the site pages, any Route Codes that you have created in any particular session. Should you wish to retrieve a specific regulatory route map, enter a Route Code in the space provided on the 'Home' or 'Regulatory Routes' pages in order to retrieve the corresponding regulatory route established from a previous session.